Nctid:
NCT00002845
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-11-01"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D008545", "term"=>"Melanoma"}], "ancestors"=>[{"id"=>"D018358", "term"=>"Neuroendocrine Tumors"}, {"id"=>"D017599", "term"=>"Neuroectodermal Tumors"}, {"id"=>"D009373", "term"=>"Neoplasms, Germ Cell and Embryonal"}, {"id"=>"D009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D009380", "term"=>"Neoplasms, Nerve Tissue"}, {"id"=>"D018326", "term"=>"Nevi and Melanomas"}, {"id"=>"D012878", "term"=>"Skin Neoplasms"}, {"id"=>"D009371", "term"=>"Neoplasms by Site"}, {"id"=>"D012871", "term"=>"Skin Diseases"}], "browseLeaves"=>[{"id"=>"M14850", "name"=>"Recurrence", "relevance"=>"LOW"}, {"id"=>"M11528", "name"=>"Melanoma", "asFound"=>"Melanoma", "relevance"=>"HIGH"}, {"id"=>"M20495", "name"=>"Neuroendocrine Tumors", "relevance"=>"LOW"}, {"id"=>"M19845", "name"=>"Neuroectodermal Tumors", "relevance"=>"LOW"}, {"id"=>"M20388", "name"=>"Neuroectodermal Tumors, Primitive", "relevance"=>"LOW"}, {"id"=>"M12318", "name"=>"Neoplasms, Germ Cell and Embryonal", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M12325", "name"=>"Neoplasms, Nerve Tissue", "relevance"=>"LOW"}, {"id"=>"M20470", "name"=>"Nevi and Melanomas", "relevance"=>"LOW"}, {"id"=>"M12446", "name"=>"Nevus", "relevance"=>"LOW"}, {"id"=>"M12448", "name"=>"Nevus, Pigmented", "relevance"=>"LOW"}, {"id"=>"M15681", "name"=>"Skin Neoplasms", "relevance"=>"LOW"}, {"id"=>"M15674", "name"=>"Skin Diseases", "relevance"=>"LOW"}, {"id"=>"T4091", "name"=>"Neuroendocrine Tumor", "relevance"=>"LOW"}, {"id"=>"T4092", "name"=>"Neuroepithelioma", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"C082598", "term"=>"Aldesleukin"}], "ancestors"=>[{"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D019380", "term"=>"Anti-HIV Agents"}, {"id"=>"D044966", "term"=>"Anti-Retroviral Agents"}, {"id"=>"D000998", "term"=>"Antiviral Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}], "browseLeaves"=>[{"id"=>"M10411", "name"=>"Interleukin-2", "relevance"=>"LOW"}, {"id"=>"M225496", "name"=>"Aldesleukin", "asFound"=>"Tacrolimus", "relevance"=>"HIGH"}, {"id"=>"M21350", "name"=>"Anti-HIV Agents", "relevance"=>"LOW"}, {"id"=>"M25428", "name"=>"Anti-Retroviral Agents", "relevance"=>"LOW"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"Analgesics", "abbrev"=>"Analg"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>20}}, "statusModule"=>{"overallStatus"=>"UNKNOWN", "lastKnownStatus"=>"ACTIVE_NOT_RECRUITING", "startDateStruct"=>{"date"=>"1995-09"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2000-05", "lastUpdateSubmitDate"=>"2013-12-18", "studyFirstSubmitDate"=>"1999-11-01", "studyFirstSubmitQcDate"=>"2004-08-23", "lastUpdatePostDateStruct"=>{"date"=>"2013-12-19", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2004-08-24", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["stage IV melanoma", "recurrent melanoma"], "conditions"=>["Melanoma (Skin)"]}, "descriptionModule"=>{"briefSummary"=>"RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells.\n\nPURPOSE: Phase II trial to study the effectiveness of interleukin-2 in treating patients who have metastatic melanoma.", "detailedDescription"=>"OBJECTIVES: I. Evaluate the response and survival rates of patients with metastatic melanoma following induction with high-dose and maintenance with low-dose interleukin-2. II. Assess the toxicity of this regimen.\n\nOUTLINE: All patients receive high-dose interleukin-2 over 24 hours, followed by low-dose interleukin-2 for 4 days in the absence of toxicity. Patients receive a second cycle beginning 9-13 days after completion of the first cycle, with response assessed approximately 2 months after initiating therapy. Patients with stable or responding disease receive a second course as above; those with a continued response may receive additional courses provided toxicity is limited. Patients are followed for survival.\n\nPROJECTED ACCRUAL: 20 patients will be entered."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS: Histologically proven melanoma that is metastatic No tumor replacement of 25% or more of liver on CT or MRI No involvement of the CNS or a major nerve Measurable disease required\n\nPATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80%-100% Life expectancy: More than 3 months Hematopoietic: No coagulopathy (i.e., platelets less than 80,000) Hepatic: Bilirubin normal Renal: Creatinine normal Cardiovascular: No abnormal cardiac stress test in patients over 50 years of age or with possible cardiac disease suggested by history, physical exam, or EKG Pulmonary: FEV1 or VC greater than 65% of predicted in patients with significant smoking history or with suspected pulmonary disease by history, physical exam, or x-ray Other: No site of ongoing bleeding No systemic infection No HIV antibody No HBsAg No requirement for steroids No psychiatric disease that precludes informed consent or protocol treatment No second malignancy except: Basal cell skin carcinoma Carcinoma in situ of the cervix No pregnant or nursing women Negative pregnancy test required of fertile women Effective contraception required of fertile women\n\nPRIOR CONCURRENT THERAPY: No prior interleukin-2 At least 28 days since treatment for melanoma"}, "identificationModule"=>{"nctId"=>"NCT00002845", "briefTitle"=>"Interleukin-2 in Treating Patients With Metastatic Melanoma", "organization"=>{"class"=>"NIH", "fullName"=>"National Cancer Institute (NCI)"}, "officialTitle"=>"TREATMENT OF METASTATIC MELANOMA WITH RECOMBINANT INTERLEUKIN-2", "orgStudyIdInfo"=>{"id"=>"CDR0000065084"}, "secondaryIdInfos"=>[{"id"=>"CMC-09-95-16B"}, {"id"=>"NCI-V96-1037"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"aldesleukin", "type"=>"BIOLOGICAL"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"28232-2861", "city"=>"Charlotte", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Carolinas Medical Center", "geoPoint"=>{"lat"=>35.22709, "lon"=>-80.84313}}], "overallOfficials"=>[{"name"=>"Richard L. White, MD", "role"=>"STUDY_CHAIR", "affiliation"=>"Blumenthal Cancer Center at Carolinas Medical Center"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Blumenthal Cancer Center at Carolinas Medical Center", "class"=>"OTHER"}}}}